FDA Adverse Event
Malfunction
Summary report: N
PVH C-SECTION PACK
MDR report key: 359013
·
Received October 31, 2001
Report
- Report Number
- MW1023249
- Event Type
- Malfunction
- Date Received
- October 31, 2001
- Date of Event
- October 1, 2001
- Report Date
- October 31, 2001
- Manufacturer
- MAXXIM MEDICAL
- Product Code
- LRO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PACK WAS MISSING MAYO STAND COVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48939 | PVH C-SECTION PACK | CUSTOM C-SECTION INSTRUMENT PACK | LRO | MAXXIM MEDICAL | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |